Common children's cold and cough medicines are coming under scrutiny from federal drug regulators, who say the remedies and their recommended doses have not been studied enough in children, a newspaper reported.
Dr Charles J. Ganley, a top Food and Drug Administration
official, said the agency was "revisiting the risks and benefits of
the use of these drugs in children," especially those under two years, The
New York Times reported in Friday's editions.
Most over-the-counter cold and cough medicines have been
insufficiently tested in children, said Ganley, the director of the
FDA's office of non-prescription drug products.
"We have no data on these agents of what's a safe and effective
dose in children," he told The Times in an interview.
The FDA said it could not yet determine whether new regulations
would result from the safety review, according to the newspaper.
A group of paediatricians and public health officials asked the
agency Thursday to bar drug manufacturers from marketing such
remedies as Toddler's Dimetapp, Infant Triaminic and Little Colds
to children under six years.
Serious problems reported
A recent study by the US federal Centres for Disease Control and
Prevention suggested that more than 1 500 children under two had
experienced serious health problems - and three had died - after taking
common cold medicines in 2004 and 2005. The American College of
Chest Physicians last year recommended avoiding using cough and
cold medicines in children, especially young ones.
In above-normal doses, cold medicines can lead to heart
arrhythmias, and some have been linked to hypertension and stroke
when taken in high doses, The Times reported. In rare cases,
children have had medical problems after taking recommended doses,
the article said.
The president of the Consumer Healthcare Products Association,
which represents companies that sell over-the-counter cold drugs,
noted that the medicines had FDA approval and had been used for
decades. They should be taken only in recommended doses,
association president Linda A. Suydam said.
Safe at right dosage
The paediatricians who petitioned the FDA Thursday acknowledged
that children's cold medicines were generally safe in recommended
doses, but they said overdoses were common because many children
were given more than one medicine, among other reasons. They also
questioned the drugs' effectiveness in children.
Many cold and cough drugs won FDA approval decades ago, when the
agency's standards were less strict, The Times reported. – (Sapa-AP)
Cold meds can kill infants
Cold or flu?